QMS : Clause wise check Points

Applicable to AS 9100 Clause All Industry : Common Standard

No. Objective Evidence
AS 9100 Rev D ( Standard Requirements ) Findings
4.0 Context of the Organization C , NC , OI
All Processes 4.1
Org & Context How  has  the  organization  determined external  and  internal  issues  relevant  to  its
Understanding purpose  and  strategic  direction? How  do  these  affect  the  ability  to  achieve
the  intended  result  of  the  QMS? How  do  you  monitor  and  review  information
about  these  internal  and  external  issues?
All Processes 4.2
Needs & How  have  you  determined  what  interested parties  are  relevant  to  the  QMS?
expectations of How  have  you  determined  what requirements  those  parties  have  that  are
interested parties relevant  to  the  QMS? . How  has  impact  or  potential  impact  been determined?
How  do  you  monitor  and  review  the information  about  interested  parties  and
their  relevant  requirements?

MR 4.3
Scope of QMS
How  have  the  boundaries and applicabilityof  the  QMS  been  used  to  establish   the
scope  of  the  organization? How  have: The  external  and  internal  issues;
The  requirements  of  relevant  interestedparties  and;The  products  and  services 
 of  theorganization  been  considered  whendetermining  the  scope  of  the  organization?
How  has  the  application  of  the  Internationalstandard  within  the  scope 
been  determined, and  how  has  it  been  applied  by  the organization?
How  have  any  requirements  of  the International  Standard  been  determined  as
not  applicable?  
Show  me  how  conformity  of products  and  services  are  not  affected  by this.
Where  is  the  scope  available?  
Where  is  it maintained  as  documented  information?
Does  it  state  what  products  and  services are  covered  by  the  QMS?
Does  it  justify  how  instances  of requirements  of  the  QMS  cannot  be applied?

All Processes 4.4

QMS & its
Processes
4.4.1 : How  has  the  QMS  been  established?  Show
me  how  this  is  implemented.  How  is  it maintained  and  continually  improved?  How
have  the  processes  been  determined  and how  do  they  interact?
How  have  the  processes  been  determined for  the  QMS?
What  are  the  inputs  and  outputs  for  those processes?
What  is  the  sequence  and  interaction  of  the processes? What  are  the  criteria,  methods,
measurement  and  related  performance indicators  needed  to  operate  and  control
those  processes? What  resources  are  needed  and  how  are these  made  available?
How  are  responsibilities  and  authorities assigned  for  those  processes?
How  are  risks  and  opportunities  considered and  what  plans  are  made  to  implement
actions  to  address  them? What  methods  are  used  to  monitor, measure and evaluate
processes and ,
ifneeded,  what  changes  are  made  to  achieve intended  results?
How  are  opportunities  to  improve  the processes  and  the  QMS  determined?

4.4.1 : Check tht the Organisational QMS shall address customer and applicable statutory and
regulatory requirements

4.4.2 : What documented inforaton exists to support  the  operation  of  processes? How is

this documented information retained ? How is confidence that the processes  are  being
caried out as planned  determined ?

4.4.2 : Verify that the Org having the documented information includes :--
Description of relevant intetested parties (See 4.2 a) , Scope of QMS including boundries &
applicability ( See 4.3 ) , Process description needed for the QMS and their application
thruout the organisation , Sequences and intereaction of the processes , Assignment of the
responsibilities and authorities for these processes .
Note : All these description can be compiled in the single document and refered to as a
quality manual

5.0 Leadership
Top Management 5.1.1 Show  me  how  top  management demonstrates  leadership  and  commitment
Leadership & w.r.t.  the  QMS  by  taking  accountability  of the  effectiveness  of  the  QMS.
Committment How  is  the  quality  policy  and  objectives established  for  the  QMS  and  how  are  they
compatible  with  the  strategic  direction  and the  organizational  context?
How  is  the  quality  policy  communicated within  the  organization?  Show  me  how  this
is  understood  and  applied. How  are  the  requirements  of  the  QMS
integrated  into  the  business  processes? How  do  you  promote  awareness  of  the
process  approach? How  do  you  ensure  that  resources  needed
for  the  QMS  area  available?
How  do  you  communicate  the  importance  of effective  quality  management?
How  do  you  communicate  the  importance  of conforming  to  the  QMS  requirements?
How  do  you  ensure  that  the  QMS  achieves its  intended  results?
How  do  you  engage,  direct  and  support people  to  contribute  to  the  effectiveness  of
the  QMS? How  do  you  promote  continual improvement?
How  do  you  support  other  relevant management  roles  to  demonstrate
leadership  in  their  areas  of  responsibility?

Top Management 5.1.2

Customer Focus
Show  me  how  top  management demonstrates  leadership  and  commitment
w.r.t.  customer  focus  ensuring  requirements and  applicable  statutory  and  regulatory
requirements  are  determined  and  met. How  are  risks  and  opportunities  that  can
affect  conformity  of  products  and  services determined?
How  is  the  ability  to  enhance  customer satisfaction  determined  and  addressed?
How  is  the  focus  on  consistently  providing products  and  services  that  meet  customer
and  applicable  statutory  and  regulatory requirements  maintained?
How  is  customer  satisfaction  maintained?

Top Management 5.1.2 (d) Check that the Product and service conformity and On time delivery performance are
measured and appropritae action is taken if planed results are not or will not be achieved .
Top Management 5.2
Quality Policy 5.2.1 How  does  top  management  establish, review  and  maintain  a  quality  policy?
How  is  it  determined  to  be  appropriate  to the  purpose  and  context  of  the
organization? Does  it  provide  a  framework  for  setting  and reviewing  quality  objectives?
Does  it  contain  a  commitment  to  satisfy applicable  requirements?
Does  it  include  a  commitment  to  continual improvement  of  the  QMS?

5.2.2 Where  is  the  quality  policy  available  as documented  information?

How  is  it  communicated? Show  me  how  it  is  understood  and  applied
within  the  organization.
How  have  you  made  it  available  to  relevant interested  parties?
 HR and Top 5.3  
Management and Org Roles ,
MR responsibilit How  does  top  management  ensure  that responsibilities  and  authorities  for  relevant
& authorities roles  are  assigned,  communicated  and understood  within  the  organization?
How  does  top  management  assign  the responsibility  and  authority  for:
Ensuring  that  the  QMS  conforms  to  the International  standard?
Ensuring  processes  are  delivering  their intended  outputs?
How is the performance of the QMS, Opportunities  for  improvement  and  the  need
for change or innovation reported to top management? How is the customer focus
promoted  within the organization? How  is  the  integrity  of  the  QMS  maintained
when  changes  to  the  QMS  are  planned  and implemented?

Pl check TOP mgt shall oppoint a specific member of the org mgt , identified as the MR , who
shall have the responsibility & authority for oversight of the above requirements . The mr
shall have the Org freedom and unresricted access to top mgt to resolve quality mgt issues .
Note :- The responsibility of MR can include liaisoin with external parties on matters realting
to QMS
6.0 Planning
All Processes 6.1.1
Action to adress How are the internal and external issues and  interested  parties  considered  when
risk & planning  for  the  QMS?
opportunities How are risk and opportunities determned and  addressed  so  that  the  QMS  can::
a)     achieve  its  intended  results;
b)     Prevent  or  reduce  undesired  effects;
c)     Achieve  continual  improvement?

All Processes 6.1.2

How  are  actions  planned  to  address  risks and  opportunities?
How  are  actions  integrated   and implemented  into  the  QMS  processes?
How  do  you  evaluate  the  effectiveness  of the  actions?
How  are  actions  taken  to  address  risks  and opportunities  determined  as  being
appropriate  to  the  potential  impact  on  the conformity  of  products  and  services?

All Processes 6.2 6.2.1 Where  are  the  quality  objectives  and  are

Quality Objective these  at  all  relevant  functions,  levels  and processes?
& Planning Are  they  consistent  with  the  quality  policy?Are  they  measureable?
Do  they  consider  applicable  requirements? Are  they  relevant  to  the  conformity  of
products  and  services  and  do  they  enhance customer  satisfaction?
Are  they  monitored?  How?  How  often? How  are  they  communicated?
How  are  they  updated? Where  is  the  documented  information  on
the  quality  objectives?
6.2.2 How  does  the  organization  determine  what
will  be  done,  with  what  resources,  when completed  and  how  will  results  be  evaluated
for  quality  objectives?
MR 6.3
Planning of How  are  changes  to  the  QMS  planned systematically?
Changes Demonstrate  the  purpose  and  potential
consequences  of  changes;Demonstrate  the  integrity  of  the  QMS;
Demonstrate  how  resources  are  made available?
Demonstrate  how  responsibility  andauthority  is  allocated  or  reallocated.

7.0 Support
7.1 All Processes, 7.1
7.1.2 HR, 7.1.3 Resources
and 7.1.4 - Admin
and Maintenance Demonstrate  how  resources  are  determined for  the  establishment,  implementation,
maintenance  and  continual  improvement  of the  QMS.
Show  me  how  the  capabilities  and constraints  on  internal  resources  are considered.
Show  me  how  needs  from  external providers  are  considered.
7.1.2  People : How  do  you  provide  persons  necessary  to
consistently  meet  customer,  applicable statutory  and  regulatory  requirements  for
the  QMS  including  the  necessary processes?
7.1.3  Infrastructure: How  do  you  determine,  provide  and
maintain  the  infrastructure  for  the  operation of  processes  to  achieve  products  and
service  conformity?
7.1.4Environment : How  do  you  determine,  provide  and
maintain  the  environment  for  the  operation of  processes  to  achieve  products  and
service  conformity?

QC

7.1.5 Monitoring & Measuring :

7.1.5.1 How are the resources determined for ensuring valid and reliable monitoring and
measuring results,where used? How do you ensure that resources provided
are  suitable for the specific monitoring and measurement activities and are maintained
to ensure continued fitness for purpose? Show me the documented information
which  is evidence of fitness for purpose of monitoring and measurement resources.
7.1.5.2 Show  me  how measurement  instruments  are:
Verified  or  calibrated  at  specified  intervals against  national  or  international
measurement  standards; If  there  are  no  standards,  show  me  the
documented  information  which  is  used  as the  basis  used  for  calibration  or  verification.
Show  me  how  measurement  instruments are  identified  to  determine  their  calibration
status.Show  me  how  they  are  safeguarded  from adjustments.
Show  me  how  they  are  safeguarded  from damage  and  deterioration.
How  do  you  determine  the  validity  of previous  measurements  if  you  find  an
instrument  to  be  defective  during  verification or  calibration?
What  appropriate  actions  can  you  take?

7.5.1.2 : The Org shall establish , implement and maintain a process for the recall of
monitoring and maeasuring equipment requiring calibraton or erification.
- The Org shall maintain a register of the monitoring and measuring equipment that includes
equipment type , unique identifiction , location , calibration or verification method ,
frequency and acceptance criteria.
- Calibration or verifiction shall be carried out under suitable environmental conditions

7.1.6 Organizational Knowledge : How  do  you  determine  necessary

knowledge  for  the  operation  of  processes?
How  do  you  determine  necessary knowledge  to  achieve  conformity  of
products  and  services?
How  do  you  maintain  this  knowledge  andhow  do  you  make  it  available  to  the  extent
necessary? How  do  you  consider  current  knowledge and  how  do  you  acquire  additional
knowledge  when  addressing  changing needs  and  trends?

HR 7.2
Competence Show me how: You determine the necessary competence
of people doing work under your control that affects quality performance;
How do you determine competence on the basis of appropriate education, training or
experience? How do you take actions to acquire necessary competence where applicable
and how do you evaluate the effectiveness
of those actions? Show me documented information where appropriate of competence.

Periodic review of the necessary competence

HR and Process 7.3
Owners Awareness How are people aware of: The quality policy? Relevant quality objectives?
Their contribution to the effectiveness of the QMS? The benefits of improved performance?
The implications of not conforming with the QMS requirements?

Awareness to include QMS procedures/manual and changes, contribution to product or

service conformity, safety and importance of ethical behavior
MR 7.4 How do you determine internal and external communications relevant to the QMS?
Communication How do you determine: What? When? With Whom? How?
Needs to include internal and external feedback relevant to the QMS
 MR 7.5 7.5.1 What documented information do you have as required by this standard?
Documented What documented information do you have as being necessary for the
Information effectiveness of your QMS?
7.5.2  Creating  and  updating Show  me  that  your  documented information  contains:
Identification; Description; In  what  media  format? Show  me  how  the 
documented  information is  reviewed  and  approved  for  suitability  and adequacy.

Note : Approval implies authorized persons & approval methods are identified for the
relevant type of documented information , as determined by the org.
7.5.3.1 Show  me  how  you  control  documented information.
Show  me  how  you  make  it  available  and suitable  for  use.
How  do  you  protect  your  documented information?
7.5.3.2 When  controlling  documented  information, how  do  you  address: Distribution;
Access; Retrieval; Use; Storage  and  preservation; Legibility; Control  of  changes;
Retention  and  disposition. How  do  you  identify  as  appropriate  and
control  documented  information  of external  origin  which  you  have  determined
as  necessary  for  the  QMS

_x0001_ Adequate protection from loss of confidentiality, improper use or loss of integrity
_x0001_ Electronic date protection—loss, unauthorized changes, unintended alteration,
corruption and physical damage
8.0 Operation
NDP / 8.1
Engineering Operational
Planning and
control How  are  processes  needed  to  meet requirements  for  provision  of  products  and
services  planned,  implemented  and controlled?
How  are  requirements  for  products  and services  determined?
How  is  criteria  for  processes  and acceptance  for  products  and  services determined?
How  are  resources  determined? How  is  process  control  implemented?
Show  me  the  documented  information that  shows  confidence  in  that  the  processes
have  been  carried  out  as  planned  and  can demonstrate  conformity  of  products  and
services.
How  have  you  determined  that  the  output from  the  planning  process  is  suitable  for
your  operations? How  do  you  control  planned  changes?  
How do  you  review  the  consequences  of unintended  changes?  
What  action  is  taken to  mitigate  any  adverse  effects?
How  do  you  control  outsourced  processes?

Determination of requirements to
consider:
_x0001_ Personal & product safety
_x0001_ Producibility & inspectability
_x0001_ Reliability, availability and maintainability
_x0001_ Suitability of part & materials used in the product
_x0001_ Selection & development of embedded software
_x0001_ Product obsolescence
_x0001_ Prevention, detection, removal of foreign objects
_x0001_ Handling, packaging & preservation
_x0001_ Recycling or final disposal of product at life end
_x0001_ Use of statistical techniques for design verification, process control (key
characteristics), critical items, design of experiments, failure mode, effects and criticality
analysis
_x0001_ Determine resources for product conformity and to meet on time delivery of
products and services
_x0001_ Determining the products and services from external providers
_x0001_ Controls to prevent the delivery of nonconforming products/services
_x0001_ Planned sequence to meet requirements of acceptable risk

NDP / 8.1.1
Engineering Operational Risk For operational risk management:
Managemnet _x0001_ Assign responsibilities
_x0001_ Define risk criteria
_x0001_ Identify, assess and communicate risk
_x0001_ Manage risks that exceed defined risk criteria
_x0001_ Acceptance of remaining risks
NDP / 8.1.2 Ensure identification & control of physical and functional attributes
Engineering Configuration
Managemnet _x0001_ Control product identity and traceability, including changes
_x0001_ Records are consistent with attributes of products and services
NDP / 8.1.3
Engineering Product Safety Plan, implement & control processes for product safety including:
_x0001_ Assessment of hazards and associated risks
_x0001_ Mange safety critical items
_x0001_ Analysis and reporting of events affecting safety
_x0001_ Communication of event
_x0001_ Employee training
NDP / 8.1.4
Engineering / Prevention of Plan, implement and control processes to prevent the introduction of CP including:
Purcahse / QC counterfit _x0001_ Training for awareness and prevention of CP
Products
_x0001_ Parts obsolescence monitoring
_x0001_ Controls for purchasing from original or authorized sources
_x0001_ Requirements for assuring traceability of parts and components to original or
authorized manufacturers
_x0001_ Verification and testing to detect CP
_x0001_ Monitoring of CP reporting
_x0001_ Quarantine and reporting of suspect to detected CP

Marketing 8.2 8.2.1 - Customer Communication :

Determination  of What  are  your  processes  for  communicating
  requirements  f with  customers?  How  do  you  communicate information  relating  to: Products; Services;
or  products  and  Enquiries; Contracts; Order  handling; Customer  views,  perceptions  and complaints;
 services Handling  or  treatment  of  customer  property; Specific  requirements  for  contingency
actions?

8.2.2  Determination  of  requirements  related  to  products  and  services
What  is  your  process  to  determine  the requirements  for  products  and  services  to
be  offered  to  potential  customers? How do,you establish, implement  and  maintain  this
process? How  do  you  define  product  and  service requirements  including  statutory  and
regulatory  requirements? How  do  you  ensure  that  you  have  the  ability
to  meet  the  defined  requirements  and substantiate  any  claims  for  your  products
Marketing 8.2.2 and  services?

Special requirements for product/services determined

_x0001_ Operational risks have been identified
 8.2.3  Review  of  requirements  related  to  products  and  services
How  do  you  review: Customer  requirements  for  delivery  and post-delivery?
Requirements  necessary  for  customers' specified  or  intended  use,  where  known;
Additional  statutory  and  regulatory requirements  applicable  to  products  and services;
Any  other  contract  or  order  requirements.
Show  me  that  the  review  is  conducted  prior to your committment to supply
products  and services  to  your  customers. How  do  you resolve contract or order
requirements which  differ  from  those  previously  defined?
How  do  you  confirm  customer  requirements where the customer does not provide a
documented  statement? Show  me  where  you  retain  documented information
which  describes  results  of  the review  including  any  new  or  changed requirements.
Marketing 8.2.3 Show  me  the  documented  information containing  changes  to  products  and
services.  How  do  you  ensure  that  relevant personnel  are  made  aware  of  those
changes?

Review of requirements coordinated with applicable functions

_x0001_ Negotiate mutual agreements with customer when requirements cannot be fully
met
Not Applicable 8.3 8.3.1 : Where  the  detailed  requirements  of  the Org products and services are not
Design  and   already  established  or  not  defined  by  the  customer or by other interested parties ,
development  of   such  that  they  are adequate  for  subsequent production  or service provision ,
products  and  se the  organization  shall  establish, implemented and maintain a design and development
rvices How  do  you  establish,  implement  and maintain a design & development process
(where  detailed  requirements  of  your products  and  services  are  not  already
established  or  defined  by  the  customer  or other  parties).

8.3.2 -Desing & Development Planning :

When  determining  the  stages  and  control for design and development , show me how
you  consider: The  nature,  duration  and  complexity  of  the activities;
Requirements  that  specify  particular process  stages  including  applicable reviews;
Required  verification  and  validation; Responsibilities  and  authorities;
How  interfaces  are  controlled  between individuals  and  parties; The need for involvenet
of  customer  and user  groups. how  me  documented  information  that
confirms  design  and  development requirements  have  been  met.

_x0001_ Divide D&D efforts into distinct activities and define tasks, resources responsibilities,
design content and inputs/outputs for each
8.3.3: Design & Development Inputs :
Can  you  show  me  how  you  determine: Requirements  essential  for  the  type  of
products  and  services  being  designed  and developed,  including  as  applicable:
Functional  &  performance  requirements; Statutory  and  regulatory  requirements;
Standards  or  codes  of  practice  where  there is  a  commitment  to  implement;
Internal  and  external  resources  needed  for the design and development of products
and  services; Potential  consequences  of  failure; Level of control expected of the
design  and development  process  by  customers  and other  relevant  parties.
How  do  you  determine  that  inputs  are adequate,  complete  and  unambiguous  for
design  and  development?  How  do  you resolve  conflicts  among  inputs?

Address potential consequences of obsolescence

8.3.4 : Design & Development Control :
How  do  controls  that  are  applied  to  the design  and  development  process  ensure:
Results  achieved  by  design  and development  activities  are  clearly  defined?
Design  and  development  reviews  are conducted  as  planned?
Outputs  meet  the  input  requirements  by verification/
Validation  is  conducted  to  ensure  that  the
resulting  products  and  services  are  capable of  meeting  the  requirements  for  the
specified  application  or  intended  use  (when known)?

_x0001_ Progression to next stage authorization

_x0001_ Participants include representativefrom all functions
8.3.4.1
Plan control and review tests for verification and validation
_x0001_ Test procedures describe test methods, how to perform and how to record
_x0001_ Ensure correct configuration of test item
_x0001_ Requirements of test plan and test procedures are observed
_x0001_ Acceptance criteria are met _x0001_ Control of monitoring/measuring devices
_x0001_ Reports to demonstrate that the design meets requirements for all operational
conditions

8.3.5 : Design & Development Outputs:

How  do  you  ensure  that  design  and development  outputs:
Meet  the  input  requirements  for  design  and development?
Are  adequate  for  the  subsequent  processes for the provision of products and
services? Include  or  reference  monitoring  and measuring requirements , and acceptance
criteria,  as  applicable? Ensure product to be produced , or service to be
provided,  are  fit  for  intended  purpose and  their  safe  and  proper  use?
Show  me  the  documented  information which  results  from  the  design  and
development  process.

_x0001_ Outputs include any critical items, key characteristics and specific actions for them
_x0001_ Are approved by authorized persons prior to release
_x0001_ Define data required to allow product to be identified, manufactured, verified, used
and maintained

8.3.6 : Design & Development Changes :

How  do  you  review,  control  and  identify changes  made  to  the  design  inputs  and
outputs  during  design  and  development  of products  and  services  ensuring  no  impact
on  conformity  to  requirements? Show  me  the  documented  information  for
design  and  development  changes.

_x0001_ Process in place for notifying customers of changes that could affect them prior to
implementation
_x0001_ Changes controlled IAW configuration management process
 Purcahse & 8.4 8.4.1 : General :
Quality Control of How  do  you  ensure  externally  provided processes,  products  and  services  conform
externally to  specified  requirements? Show  me  how  you  apply  specified
provided requirements  for  the  control  of  externally provided  products  and  services  when:
processes , Products  and  services  are  provided  by external  providers  for  incorporation  into  your
Product and own  products  and  services; You  provide  products  and  services  directly
Services to  customers  by  external  providers  on  your behalf; A  process  or  part-process  is 
provided  by  an external  provider  as  a  result  of  a  decision  to
outsource  a  process  or  function. Show  me  how  you  establish  and  apply
criteria  for  evaluation,  selection,  monitoring of  performance  and  re-evaluation  of
external  providers.  How  do  you  assess  their
ability  to  provide  processes  or  products  and services  in  accordance  with  specified
requirements? What  documented  information  do  you
have  of  the  results  of  evaluations, monitoring  of  performance  and  re-
evaluations  of  external  providers?

Apply appropriate controls to direct and sub-tier external providers as well as

selection and use of external providers
8.4.1.1 : Define the process Resp , and authority for the approval status decision , change of
approval status , condition for a controlled use of external providers depending on their
approval status , maintain a register , periodocally review , necessary action , define a
requirement for controlling documented information

8.4.2 : Type and Extent of control

How  do  you  determine  the  controls  applied to  the  external  provision  of  processes,
products  and  services  and  take  into consideration:
a)  The  potential  impact  of  the  externally provided processes , products and services
on  the  ability  to  consistently  meet  customer and applicable statutory and regulatory
requirements?
b)  The  perceived  effectiveness  of  the controls  applied  by  the  external  provider?
What  verification  or  other  activities  do  you have  to  ensure  externally provided
processes,  products  and  services  do  not adversely affect your ability to consistent
deliver  conforming  products  and  services  to your  customers?
When  processes  or  functions  have  been outsourced  to  external  providers,  how  do
you  consider  a)  and  b)  in  8.4.1  and  how  do you define the controls you define the
controls  intended  to  be applied  to  the  external  provider  and  to  the resulting process
output?

_x0001_ Verification activities performed according to identified risks _x0001_ Include

inspection or periodic testing when high risk ofnonconformities and counterfeit parts
_x0001_ Review of production part approval process data
_x0001_ Review of delegations of product verification
_x0001_ Define process for pre-release of product
_x0001_ Evaluate data in test reports to confirm product meets requirements
_x0001_ When purchase of raw material is a significant operations risk, implement a
process to validate the accuracy of test reports

8.4.3: Information for External Providers

Show  me  how  you  communicate  to  external providers,  applicable  requirements  for:
Products  and  services  to  be  provided  or  the
processes  to  be  performed  on  behalf  of  the organization;
Approval  or  release  of  products  and services,  methods,  processes  or  equipment;
Competence  of  personnel,  including necessary  qualification;
Their  interactions  with  the  organization's quality  management  system;
The  control  and  monitoring  of  the  external
provider's  performance  to  be  applied  by  the organization;
Verification  activities  that  the  organization, or  its  customer,  intends  to  perform  at  the
external  provider's  premises. Before  you  communicate  with  external
providers,  how  do  you  ensure  the  adequacy of  specified  requirements?

Communicate external providers with information including

_x0001_ Relevant technical data _x0001_ Design and development control
_x0001_ Special requirements _x0001_ Prevent the use of counterfeit parts
_x0001_ Ensuring that supplier personnel are aware of their contribution to product/service
conformity, safety and ethical behavior

Production, 8.5 8.5.1 : Control of Production & Service Provision :

Stores and Production and What  controlled  conditions  do  you  have  for production service provision , including
Quality and NDP- Service Provision delivery  and  post-delivery  activities? Can  you  show  me  controlled  conditions  for:
Engineering a)  the  availability  of  documented  information defining the charactestics of the products
and  services;
b)  the  availability  of  documented information  defining  the  activities  to  be
performed  and  the  results  to  be  achieved;
c)  monitoring  and  measurement  activities  at appropriate stage to verify that criteria for
control  of  processes  and  process  outputs, and acceptance criteria for products and
services,  have  been  met.
d)  the  use,  and  control  of  suitable infrastructure  and  process  environment;
e)  the  availability  and  use  of  suitable monitoring  and  measuring  resources;
f)  the  competence  and,  where  applicable, required  qualification  of  persons;
g)  the  validation,  and  periodic  revalidation, of the ability to achieve planned results of
 process  for  production  and  service provision  where  the  resulting output  cannot
be  verified  by  subsequent  monitoring  or measurement;
h)  the  implementation  of  products  and services  release,  delivery  and  post-delivery
activities.

Ensure that documented information (procedures, work instructions for monitoring and
measurement (M&M) activity for product acceptance includes:
_x0001_ Criteria for acceptance and rejection
_x0001_ Where in sequence verification operations occur
_x0001_ Measurement results to be retained
_x0001_ Any specific M&M equipment required and instructions for their use

8.5.1.1 Control of Production Equipment, Tools and Software Programs

8.5.1.2 Validation and Control of Special Processes
8.5.1.3 Production Process Verification

8.5.2 : Identification & Traceability :

What  means  do  you  use  to  identify  process output to ensure conformity of product
and  services? How  do  you  identify  the  status  of  process outputs?
How  do  you  control  the  unique  identification of process putputs , whereas applicable ?
What documented  information  do  you  retain ?

Maintain the identification of the configuration of products and services in order to identify
any differences between the actual configuration and required configuration.
 8.5.3: Property belonging to Customers and external Providers
What care do you provide for customer or external provider's property while under
your control?
How do you identify, verify, protect and safeguard that property which is provided
for use or incorporation into your products or services?
What means do you use to report to the customer or external provider if their
property is incorrectly used, lost, damaged or found to be unsuitable for use?

8.5.4 :Preservation :
How do you ensure preservation of process outputs during production and service
provision to maintain conformity to product requirements?

Preservation of output shall also include , when applicable in accordance with spec and
applicabe statutory and regulatory requiremnets , provision for - Cleaning , prevention ,
detection and removal of foreign objects , special ahandling and storag e, marking and
labelling , including safety warnings , shelf life control and stock rotation .

8.5.5 : Post Delivery Activities

How do you meet requirements for post-delivery activities associated with products
and services?
How do you determine: Risk; Nature, use and intended lifetime; Customer feedback;
Statutory and Regulatory requirements, when determining the extent of post-delivery
activities required with products and services?

Post-delivery activities to include: control, updating, and provision of technical

documentation relating to product use, maintenance, repair, and overhaul.
8.5.6: Control of changes :
How do you review and control unplanned changes to ensure continuing conformity
with specified requirements?
What documented information can you show me which describes the results of
reviews of changes, the personnel authorizing change and any necessary actions?

Persons quthorized to approve production or service provision chnages shall be identified

QC 8.6
Release of Show  me  how  planned  arrangement  have been  implemented  at  appropriate  stages  to
Products and verify  product  and  service  requirements have  been  met.  Show  me  what  evidence
Services you  retain. Show  me  how  the  release  of  products  and
services  is  held  until  planned  arrangements for  verification  of  conformity  have  been
satisfactorily  completed,  unless  approved  by a  relevant  authority,  or  the  customer  if
applicable.  Show  me  documented information  which  shows  traceability  to  the
person  authorizing  release  of  products  and services.

New sub clause to address the verification of product/service at appropriate stages

_x0001_ Retain documented information on the release of products/services including
evidence of conformity and traceability to person authorizing the release
QC 8.7
Control of Non
conforming
Outputs How  do  you  identify  and  control  process outputs,  products  and  services  that  do  not
conform  to  requirements  and  prevent  their unintended  use  or  delivery?
What  appropriate  corrective  actions  are taken  based  on  the  nature  of  the
nonconformity  and  its  impact  on  the conformity  of  products  and  services?  How
do  you  apply  this  to  nonconformity  detected after  delivery?
How  you  deal  with  nonconforming  process outputs,  products  and  services  in  terms  of:
Correction;
Segregation,  containment,  return  or suspension  of  provision  of  products  and services?
Informing  the  customer? Obtaining  authorization  for  use  as-is?
Release,  continuation  or  re-provision  of  the products  and  service?
Acceptance  under  concession? How  do  you  verify  conformance  where
process  outputs,  products  and  services  are corrected  following  nonconformance?
What  documented  information  do  you keep  following  actions  taken  to  address
nonconformities,  including  any  concessions
obtained  and  on  the  person  or  authority  that made  the  decision  regarding  dealing  with
the  nonconformance.

QC
Nonconforming “Product” replaced with “Output”
_x0001_ Include provisions for defining corrective actions for nonconforming products and
services detected after delivery, as appropriate to their impacts
_x0001_ Dispositions for use-as-is or repair to include obtaining authorization for acceptance
under concession by a relevant authority and, when applicable, by the customer.
_x0001_ After authorization by the customer, if the nonconformity results in a departure
from the contract requirements
_x0001_ Counterfeit, or suspect counterfeit, parts to be controlled to prevent reentry into
the supply chain.

9.0 Performance Evaluation

All Processes 9.1  
Monitoring,  
measurement,   9.1.1 Show  me  how  you  determine:
analysis  and   What  needs  to  be  monitored  and measured? Methods  for  monitoring,  measurement,
evaluation analysis  and  evaluation  to  ensure  valid results?
When  to  perform  monitoring  and measuring? When  results  shall  be  analysed  and
evaluated? What  documented  information  can  you
show  me  that  monitoring  and  measurement activities  have  been  implemented  in
accordance  with  determined  requirements? Show  me  how  you  evaluate  the  quality
performance  and  the  effectiveness  of  the QMS.

Marketing 9.1.2 Customer

satisfaction How  do  you  monitor  customer  perception  of
the  degree  to  which  requirements  have been  met?
How  do  you  obtain  information  relating  to customer  views  and  opinions  of  your
products  and  services?
What  methods  for  obtaining  and  using  this information  do  you  have?
Information to be monitored and used for evaluation of customer satisfaction , but not
limited to , product and service conformity , on time delivery , complaints ,and CAPA request .
The Org shall develop & implemnet the plans that address deficiencies identified by these
evaluations and assess the effectiveness of the results.
All Processes 9.1.3 Analysis &
Evaluation
How  you  analyse  and  evaluate  data and  information  arising  from  monitoring,
measurement  and  other  sources.
Show  me  how  the  output  of  analysis  and evaluation  is  used  to:
Demonstrate  conformity  of  products  and services  to  requirements?
Assess  and  enhance  customer  satisfaction? Ensure  conformity  and  effectiveness  of  the
QMS? Demonstrate  that  planning  has  been successfully  implemented?
Assess  process  performance? Assess  performance  of  external  providers?
Determine  the  need  or  opportunities  for improvements  within  the  QMS?
Show  me  where  the  results  of  analysis  and evaluation  are  used  to  provide  inputs  to
management  review.

Note : Appropriate data can include information on product and service problems reported by
external sources ( eg Government /Industry alerts , advisories )
MR 9.2 9.2.1 Are  internal  audits  being  conducted  at planned  intervals?  Do  they  determine
Internal Audit whether  the  QMS  conforms  to  the requirements  of  ISO  9001  and  to  the  other
requirements  established  by  Organization? (Review  records  to  demonstrate conformance)
Do  they  determine  whether  the  QMS  is effectively  implemented  and  maintained?
(Review  records)
 Note : The org own requirements should include and applicable statutory and regulatory QMS
requirements
-When Conducting internal audits , performance indicators can be evaluated to determine
whether the QMS is effectively implemented and maintained .

9.2.2 Can  you  show  me  audit  programme(s)  that takes  into  consideration  the  quality

objectives,  importance  of  the  processes, customer  feedback,  changes  impacting  the
organization  and  the  results  of  previous audits?
Where  are  the  audit  criteria  and  scope  for each  audit?
Can  you  demonstrate  that  selection  of
auditors  and  the  conduct  of  audits  are objective  and  impartial  and  that  auditors
don't  audit  their  own  work? How  are  audit  results  reported  to  relevant management?
Can  you  demonstrate  that  necessary correction  and  corrective  actions  are  taken
without  undue  delay? Can  you  show  me  documented
information  of  the  audit  programme  and the  audit  results?

MR 9.3
Managemnt
Review 9.3.1- What  is  the  frequency  that  top  management
reviews  the  organization's  QMS?  How  is the  QMS  deemed  suitable,  adequate  and
effective?
9.3.2 - What  kinds  of  information  are  reviewed  in
management  reviews?  These  must  include: actions  status  of  previous  reviews;
changes  to  internal/external  issues  relevant to  the  QMS; issues  that  affect  strategy;
KPIs  for  nonconformities  and  corrective actions; monitor  and  measurement  of  results;
audit  results;
customer  satisfaction; issues  concerning  external  providers;
issues  concerning  other  relevant  parties;adequacy  of  resources  and  effectiveness  of
QMS;
process  performance; conformity  of  products  and  services;
actions  taken  to  address  risks  and opportunities  and  their  effectiveness;
new  potential  opportunities  for  continual improvement.

9.3.3 - Show  me  that  management  outputs reviews  include

decisions  and  actions  relating  to: Continual  improvement  opportunities;
The  need  for  changes  to  the  QMS  including resource  needs.
Show  me  what  documented  information you  have  as  evidence  of  management reviews.

Risk identified shall also includes in mgt review output

10.0 Improvemnet
All Processes 10.1
General How  do  you  determine  and  select opportunities  for  improvement?  What
necessary  actions  have  you  implemented so  that  you  have  met  customer
requirements  and  enhanced  customer satisfaction?
Show  me  how  you  have: Improved  processes  to  prevent nonconformities;
Improved  products  and  services  to  meet known  and  predicted  requirements;
Improved  QMS  results.

MR and QC 10.2 10.2.1 - When  nonconformities  occur,  

NC and a) Show  me  how; You  react; Take  action  to  control  and  correct  it;
Corrective Deal  with  the  consequences; b & c ) Evaluate  the  need  for  action  to  eliminate  the
atcions cause  so  that  it  does  not  recur  or  occur elsewhere  by: d)Reviewing  the  nonconformity;
Determining  the  cause  of  the  nonconformity;
e) Determining  if  similar  nonconformities  exist or  could  potentially  occur;
Actions  needed  are  implemented; Review  the  effectiveness  of  corrective
actions  taken,  if  any;
f) Make  necessary  changes  to  the  QMS.
- Show  me  how  correction  actions  were appropriate  to  the  effects  of the
nonconformities  encountered.

g) Flow down corrective action requirements to an external provider when it is determined

that the extenal provider is responsible for the non conformity.
h) Take specific actions when timely and effective corrective actions are not achieved .
- The org shall maintain documented informtion that defines the non conformity and
corrective action managemnt process .

10.2.2-What  documented  information  can  you
show  me  as  evidence  of:The  nature  of  the  nonconformities  and
subsequent  actions  taken; The  results  of  any  corrective  action.

All Processes 10.3

Continual Demonstrate  that  you  continually  improve the  suitability,  adequacy  and  effectiveness
Improvemnet of  the  QMS. Demonstrate  that  outputs  of  analysis  and
evaluation  and  the  outputs  from management  review  are  considered  to
confirm  if  there  are  areas  of underperformance  or  opportunities  that  shall
be  addressed  as  part  of  continual improvement.
What  applicable  tools  and  methodologies for  investigation  of  the  causes  of
underperformance  and  to  support  continual improvement  are  selected?
The org shall monitor the implementation of improvement activities and evaluate the
effectiveness of the results.
Note : Examples of continual improvemnet opportunities can include lesson learned ,
problem resolutions , and the benchmarking of best practices